Health Professional FAQs

Below are commonly asked questions about Mifeprex*(mifepristone).

If you have a question that is not answered by this section, please contact us.

Q1: What is Mifeprex?

A1: Mifeprex is a pill that blocks a hormone necessary to sustain pregnancy. Mifeprex is indicated, in a regimen with misoprostol, for the medical termination of intrauterine pregnancy through 70 days gestation. For purposes of this treatment, pregnancy is dated from the first day of the last menstrual period.

Q2: How Does Mifeprex work?

A2: Use of Mifeprex in a regimen with misoprostol disrupts pregnancy by causing decidual necrosis, myometrial contractions, and cervical softening, leading to the expulsion of the products of conception.

For more detailed information on the clinical pharmacology of Mifeprex you may wish to review that section of the Prescribing Information (PDF).

Q3: When is Mifeprex appropriate?

A3: Mifeprex is indicated, in a regimen with misoprostol, for the medical termination of intrauterine pregnancy through 70 days gestation. The duration of pregnancy may be determined from menstrual history and by clinical examination. Assess the pregnancy by ultrasonographic if the duration of pregnancy is uncertain, or if ectopic pregnancy is suspected.

Mifeprex should not be used in cases of confirmed or suspected ectopic pregnancy, as it is not effective for terminating those pregnancies.

Contraindications
• Administration of Mifeprex and misoprostol for the termination of pregnancy is contraindicated in patients with any of the following conditions:
– Confirmed or suspected ectopic pregnancy or undiagnosed adnexal mass (the treatment procedure will not be effective to terminate an ectopic pregnancy)
– Chronic adrenal failure (risk of acute renal insufficiency)
– Concurrent long-term corticosteroid therapy (risk of acute renal insufficiency)
– History of allergy to mifepristone, misoprostol, or other prostaglandins (allergic reactions including anaphylaxis, angioedema, rash, hives, and itching have been reported)
– Hemorrhagic disorders or concurrent anticoagulant therapy (risk of heavy bleeding)
– Inherited porphyrias (risk of worsening or of precipitation of attacks)
• Use of MIFEPREX and misoprostol for termination of intrauterine pregnancy is contraindicated in patients with an intrauterine device (“IUD”) in place (the IUD might interfere with pregnancy termination). If the IUD is removed, MIFEPREX may be used.

Q4: How effective is Mifeprex?

A4: Mifeprex is 93-98% effective for safely ending pregnancy (2-7% of women will need a surgical procedure to end the pregnancy or stop heavy bleeding).

For more information on the efficacy of Mifeprex you may want to review the Clinical Studies section of the Prescribing Information (PDF).

Q5: Why should I consider prescribing Mifeprex?

A5: Mifeprex offers patients a choice. It is taken orally and allows women to avoid surgery and anesthesia in most cases. With Mifeprex, women can act early and up to 70 days from the beginning of the last menstrual period. Overall, many women like the privacy of using Mifeprex.

Q6: What important safety information should I know about Mifeprex?

A6:

WARNING: SERIOUS AND SOMETIMES FATAL INFECTIONS OR BLEEDING

Serious and sometimes fatal infections and bleeding occur very rarely following spontaneous, surgical, and medical abortions, including following MIFEPREX use. No causal relationship between the use of MIFEPREX and misoprostol and these events has been established.

Atypical Presentation of Infection. Patients with serious bacterial infections (e.g., Clostridium sordellii) and sepsis can present without fever, bacteremia or significant findings on pelvic examination. Very rarely, deaths have been reported in patients who presented without fever, with or without abdominal pain, but with leukocytosis with a marked left shift, tachycardia, hemoconcentration, and general malaise. A high index of suspicion is needed to rule out serious infection and sepsis.

Prolonged heavy bleeding may be a sign of incomplete abortion or other complications and prompt medical or surgical intervention may be needed. Advise patients to seek immediate medical attention if they experience prolonged heavy vaginal bleeding.

Because of the risks of serious complications described above, MIFEPREX is only available through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the MIFEPREX REMS Program.

Before prescribing MIFEPREX, inform the patient about these risks. Ensure the patient knows whom to call and what to do, including going to an Emergency Room if none of the provided contacts are reachable, if she experiences sustained fever, severe abdominal pain, prolonged heavy bleeding, or syncope, or if she experiences abdominal pain or discomfort or general malaise (including weakness, nausea, vomiting or diarrhea) for more than 24 hours after taking misoprostol.

Advise the patient to take the MEDICATION GUIDE with her if she visits an emergency room or another healthcare provider who did not prescribe MIFEPREX, so that provider knows that she is undergoing a medical abortion.

Indications and Usage

Mifeprex is indicated, in a regimen with misoprostol, for the medical termination of intrauterine pregnancy through 70 days gestation.

Contraindications

Administration of MIFEPREX and misoprostol for the termination of pregnancy is contraindicated in patients with any of the following conditions:

Confirmed or suspected ectopic pregnancy or undiagnosed adnexal mass (the treatment procedure will not be effective to terminate an ectopic pregnancy)

Inherited porphyrias (risk of worsening or of precipitation of attacks)

Use of MIFEPREX and misoprostol for termination of intrauterine pregnancy is contraindicated in patients with an intrauterine device (“IUD”) in place (the IUD might interfere with pregnancy termination). If the IUD is removed, MIFEPREX may be used.

Warnings and Precautions

Infection and Sepsis

As with other types of abortion, cases of serious bacterial infection, including very rare cases of fatal septic shock, have been reported following the use of MIFEPREX. Healthcare providers evaluating a patient who is undergoing a medical abortion should be alert to the possibility of this rare event. A sustained (> 4 hours) fever of 100.4°F or higher, severe abdominal pain, or pelvic tenderness in the days after a medical abortion may be an indication of infection.

A high index of suspicion is needed to rule out sepsis if a patient reports abdominal pain, discomfort, or general malaise (including weakness, nausea, vomiting or diarrhea) more than 24 hours after taking misoprostol. Very rarely, deaths have been reported in patients who presented without fever, with or without abdominal pain, but with leukocytosis with a marked left shift, tachycardia, hemoconcentration, and general malaise.

Uterine Bleeding

Uterine bleeding occurs in almost all patients during a medical abortion. Prolonged heavy bleeding (soaking through two thick full-size sanitary pads per hour for two consecutive hours) may be a sign of incomplete abortion or other complications and prompt medical or surgical intervention may be needed to prevent the development of hypovolemic shock. Counsel patients to seek immediate medical attention if they experience prolonged heavy vaginal bleeding following a medical abortion.

Women should expect to experience vaginal bleeding or spotting for an average of 9 to 16 days. Women report experiencing heavy bleeding for a median direction of 2 days. Up to 8% of all subjects may experience some type of bleeding for 30 days or more. In general, the duration of bleeding and spotting increased as the duration of the pregnancy increased.

Mifeprex is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the MIFEPREX REMS Program, because of the risks of serious complications. Notable requirements of the MIFEPREX REMS Program include the following:

Prescribers must be certified with the program by completing the Prescriber Agreement Form.

Patients must sign a Patient Agreement Form.

MIFEPREX must be dispensed to patients only in certain healthcare settings, specifically clinics, medical offices and hospitals by or under the supervision of a certified prescriber

Ectopic Pregnancy

MIFEPREX is contraindicated in patients with a confirmed or suspected ectopic pregnancy because MIFEPREX is not effective for terminating ectopic pregnancies. Healthcare providers should remain alert to the possibility that a patient who is undergoing a medical abortion could have an undiagnosed ectopic pregnancy because some of the expected symptoms experienced with a medical abortion (abdominal pain, uterine bleeding) may be similar to those of a ruptured ectopic pregnancy.

Women who became pregnant with an IUD in place should be assessed for ectopic pregnancy.

Rhesus Immunization

The use of MIFEPREX is assumed to require the same preventive measures as those taken prior to and during surgical abortion to prevent rhesus immunization.

Adverse Reactions

Most common adverse reactions (>15%) are nausea, weakness, fever/chills, vomiting, headache, diarrhea, and dizziness. The frequency of adverse reactions varies between studies and may be dependent on many factors including the patient population and gestational age.

Q7: How is Mifeprex provided to patients?

A7: Mifeprex is only available in medical offices, clinics and hospitals and not through retail pharmacies.

Day 1: One 200mg tablet of Mifeprex is taken in a single oral dose.

24 to 48 hours after taking Mifeprex: tell the patient to place 2 tablets of misoprostol in each cheek pouch (area between cheek and gums) for 30 minutes and then swallow any remnants with water or another liquid.

Discuss with your patient an appropriate location for her to be when she takes the misoprostol, taking into account that expulsion could begin within 2 hours of administration.

Most women will pass the pregnancy within 2 to 24 hours after taking the misoprostol tablets.

During the period immediately following the administration of misoprostol, the patient may need medication for cramps or gastrointestinal symptoms.

Post-treatment Assessment Day 7 to 14: Patients should follow-up with their healthcare provider approximately 7-14 days after the administration of Mifeprex. This assessment is very important to confirm that complete termination of pregnancy has occurred and to evaluate the degree of bleeding. Termination can be confirmed by medical history, clinical examination, human Chorionic Gonadotropin (hCG) testing, or ultrasonographic scan.

Surgical evacuation is recommended to manage ongoing pregnancies after medical abortion. Advise the patient whether you will provide such care or will refer her to another provider as part of counseling prior to prescribing Mifeprex.

For consultation 24 hours a day, 7 days a week with an expert in mifepristone, call Danco Laboratories at 1-877-4 Early Option (1-877-432-7596).

For more detailed information on the Mifeprex Dosage and Administration, you may want to review this section of the Prescribing Information (PDF). For more information about what to discuss with patients before dispensing Mifeprex, click here.

Q8: Is there important information that I should discuss with patients before dispensing Mifeprex?

A8: It is important to help your patients understand the benefits and risks of the Mifeprex regimen before dispensing Mifeprex. Advise the patient to read the Medication Guide (PDF), included with each package of Mifeprex. The Medication Guide and the Patient Agreement Form are available in multiple languages by clicking here. Hard copies of the Medication Guide are available by contacting Danco Laboratories at 1-877-4 Early Option (1-877-432-7596) or info@earlyoptionpill.com.

Serious Infections and Bleeding

Inform the patient that uterine bleeding and uterine cramping will occur.

Advise the patient that serious and sometimes fatal infections and bleeding can occur very rarely.

MIFEPREX is only available through a restricted program called the MIFEPREX REMS Program. Under the Mifeprex REMS Program:

MIFEPREX is only available in clinics, medical offices and hospitals and not through retail pharmacies.

Provider Contacts and Actions in Case of Complications

Ensure that the patient knows whom to call and what to do, including going to an Emergency Room if none of the provided contacts are reachable, or if she experiences complications including prolonged heavy bleeding, severe abdominal pain, or sustained fever.

Advise the patient to take the Medication Guide with her if she visits an emergency room or another healthcare provider who did not prescribe MIFEPREX, so that provider will be aware that the patient is undergoing a medical abortion with MIFEPREX.

if the treatment fails and the pregnancy continues, the risk of fetal malformation is unknown,

it is recommended that ongoing pregnancy be managed by surgical termination. Advise the patient whether you will provide such care or will refer her to another provider.

Subsequent Fertility

Inform the patient that another pregnancy can occur following medical abortion and before resumption of normal menses.

Inform the patient that contraception can be initiated as soon as pregnancy expulsion has been confirmed, or before she resumes sexual intercourse.

Q9:What are the most common side effects can patients expect?

A9: About 85% of patient report at least one adverse reaction following administration of Mifeprex and misoprostol, and many can be expected to report more than one such reaction. The most commonly reported adverse reactions (>15%) were nausea, weakness, fever/chills, vomiting, headache, diarrhea, and dizziness.

Abdominal pain/cramping is expected in all medical abortion patients and its incidence is not reported in clinical studies. Treatment with MIFEPREX and misoprostol is designed to induce uterine bleeding and cramping to cause termination of an intrauterine pregnancy. Uterine bleeding and cramping are expected consequences of the action of MIFEPREX and misoprostol as used in the treatment procedure. Most women can expect bleeding more heavily than they do during a heavy menstrual period

Women should expect to experience vaginal bleeding or spotting for an average of 9 to 16 days. Women report experiencing heavy bleeding for a median duration of 2 days. Up to 8% of all subjects may experience some type of bleeding for 30 days or more. In general, the duration of bleeding and spotting increased as the duration of the pregnancy increased.

You should ensure that your patient knows whom to call and what to do, including going to an Emergency Room with her Medication Guide if none of the provided contacts are reachable, if she experiences sustained fever, severe abdominal pain, prolonged heavy bleeding, syncope, or general malaise more than 24 hours after taking misoprostol.

You should discuss with your patients how to manage any pain or other side effects.

Q10: What kind of follow-up care is necessary?

A10: Patients should follow-up with their healthcare provider approximately 7 to 14 days after the administration of MIFEPREX. This assessment is very important to confirm that complete termination of pregnancy has occurred and to evaluate the degree of bleeding. Termination can be confirmed by medical history, clinical examination, human Chorionic Gonadotropin (hCG) testing, or ultrasonographic scan. Lack of bleeding following treatment usually indicates failure; however, prolonged or heavy bleeding is not proof of a complete abortion.

The existence of debris in the uterus (e.g., if seen on ultrasonography) following the treatment procedure will not necessarily require surgery for its removal.

Women should expect to experience vaginal bleeding or spotting for an average of 9 to 16 days. Women report experiencing heavy bleeding for a median duration of 2 days. Up to 8% of women may experience some type of bleeding for more than 30 days. Persistence of heavy or moderate vaginal bleeding at the time of follow-up, however, could indicate an incomplete abortion.

If complete expulsion has not occurred, but the pregnancy is not ongoing, women may be treated with another dose of misoprostol 800 mcg buccally. There have been rare reports of uterine rupture in women who took Mifeprex and misoprostol, including women with prior uterine rupture or uterine scar and women who received multiple doses of misoprostol within 24 hours. Women who choose to use a repeat dose of misoprostol should have a follow-up visit with their healthcare provider in approximately 7 days to assess for complete termination.

Surgical evacuation is recommended to manage ongoing pregnancies after medical abortion. Advise the patient whether you will provide such care or will refer her to another provider as part of counseling prior to prescribing MIFEPREX.

For more detailed information on the administration of Mifeprex, you may want to review the Prescribing Information (PDF).

Q11: Who should not take Mifeprex?

A11:

Administration of MIFEPREX and misoprostol for the termination of pregnancy (the “treatment procedure”) is contraindicated in patients with any of the following conditions:

Confirmed or suspected ectopic pregnancy or undiagnosed adnexal mass (the treatment procedure will not be effective to terminate an ectopic pregnancy)

Inherited porphyrias (risk of worsening or of precipitation of attacks)

Use of MIFEPREX and misoprostol for termination of intrauterine pregnancy is contraindicated in patients with an intrauterine device (“IUD”) in place (the IUD might interfere with pregnancy termination). If the IUD is removed, MIFEPREX may be used.

Q12: Can women who are breastfeeding also take Mifeprex?

A12: Mifeprex is present in human milk. Limited data demonstrate undetectable to low levels of the drug in human milk with the relative (weight-adjusted) infant dose 0.5% or less as compared to maternal dosing. There is no information on the effects of Mifeprex in a regimen with misoprostol in a breastfed infant or on milk production. Refer to misoprostol labeling for lactation information with the use of misoprostol. The developmental and health benefits of breast-feeding should be considered along with any potential adverse effects on the breast-fed child from Mifeprex in a regimen with misoprostol.

For more information about use of Mifeprex in Specific Populations, please review this section of the Prescribing Information (PDF).

Q13: Is Mifeprex covered by insurance?

A13: Insurance coverage of Mifeprex is generally comparable to that for surgical abortion. Mifeprex is generally covered by private insurance companies and Medicaid in the same way as surgical abortions. There is no CPT code for the Mifeprex* regimen as a whole. As a result, most payers will reimburse for each component separately.

For many payers, the office visits during which the provider administers Mifeprex may be billed using an appropriate evaluation and management (E/M) code for a new or established patient as supported by the documentation in the medical record and consistent with applicable billing and coding rules.
Many payers reimburse providers for the cost of the drug itself using a J code. Payment is often made as a pass through based on the actual invoice cost of the drug.

Federal law only requires state Medicaid programs to cover abortion in cases of rape or incest, or when the woman’s life is in danger. However, some states go beyond the minimum coverage set by the federal guidelines, and cover abortions, including Mifeprex, in other circumstances. For more information about state payer policies click here. To read more about insurance coverage of Mifeprex, including reimbursement codes, click here.

Please note the following:
• All codes supplied by us are for informational purposes only and represent no statement or guarantee that these codes will be appropriate or that reimbursement will be made in a particular situation.
• It is always the provider’s responsibility to determine and submit appropriate codes, charges, and modifiers for services that are rendered.
• All coding and reimbursement information is subject to change without notice, and specific payers may have their own coding and reimbursement requirements and policies. Before filing any claims, providers should verify current requirements and policies with the payer. We also recommend that providers stay current with National Correct Coding Initiative (NCCI) coding manual narratives and edits.
• Current Procedural Terminology (CPT) codes are copyrighted 2016 by the American Medical Association, all rights reserved. No fee schedules, basic units, relative values, or related listings are included in the CPT. The AMA assumes no liability for the data contained therein. Applicable FARS/DFARS restrictions apply to government use. Payments may be subject to reduced payment when multiple procedures are performed on the same day.

Q14: What experience has there been with Mifeprex?

A14: In the years since FDA approval of Mifeprex, more than 3 Million women in the United States have chosen Mifeprex for ending early pregnancy.

For more information on resources related reproductive health data and statistics in the United States you may want to visit the Patient Resources section of this site.

Q15: What is the Mifeprex REMS Program?

A15: Because of the risks of serious complications, Mifeprex is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the MIFEPREX REMS Program.

Notable Requirements of the Mifeprex REMS Program include the following:

Q16: What type of healthcare provider can provide Mifeprex?

A16: Mifeprex is only available in clinics, medical offices and hospitals and not through retail pharmacies. Mifeprex must be provided by or under the supervision of a healthcare provider who prescribes and meets the following qualifications:

Ability to assess the duration of pregnancy accurately.

Ability to diagnose ectopic pregnancies.

Ability to provide surgical intervention in cases of incomplete abortion or severe bleeding, or have made plans to provide such care through others, and are able to assure patient access to medical facilities equipped to provide blood transfusions and resuscitation if necessary.

Q17: How can I order Mifeprex for a patient?

Any information you provide is kept confidential. Once your account is established, you usually will receive your order within 24 hours. This is a one-time only process; future orders can be made over the phone.

Important Safety Information

WARNING: SERIOUS AND SOMETIMES FATAL INFECTIONS OR BLEEDING

Serious and sometimes fatal infections and bleeding occur very rarely following spontaneous, surgical, and medical abortions, including following MIFEPREX use. No causal relationship between the use of MIFEPREX and misoprostol and these events has been established.

Atypical Presentation of Infection. Patients with serious bacterial infections (e.g., Clostridium sordellii) and sepsis can present without fever, bacteremia or significant findings on pelvic examination. Very rarely, deaths have been reported in patients who presented without fever, with or without abdominal pain, but with leukocytosis with a marked left shift, tachycardia, hemoconcentration, and general malaise. A high index of suspicion is needed to rule out serious infection and sepsis.

Prolonged heavy bleeding may be a sign of incomplete abortion or other complications and prompt medical or surgical intervention may be needed. Advise patients to seek immediate medical attention if they experience prolonged heavy vaginal bleeding.

Because of the risks of serious complications described above, MIFEPREX is only available through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the MIFEPREX REMS Program.

Before prescribing MIFEPREX, inform the patient about these risks. Ensure the patient knows whom to call and what to do, including going to an Emergency Room if none of the provided contacts are reachable, if she experiences sustained fever, severe abdominal pain, prolonged heavy bleeding, or syncope, or if she experiences abdominal pain or discomfort or general malaise (including weakness, nausea, vomiting or diarrhea) for more than 24 hours after taking misoprostol.

Advise the patient to take the MEDICATION GUIDE with her if she visits an emergency room or another healthcare provider who did not prescribe MIFEPREX, so that provider knows that she is undergoing a medical abortion.

Indications and Usage

Mifeprex is indicated, in a regimen with misoprostol, for the medical termination of intrauterine pregnancy through 70 days gestation.

Contraindications

Administration of MIFEPREX and misoprostol for the termination of pregnancy is contraindicated in patients with any of the following conditions:

Confirmed or suspected ectopic pregnancy or undiagnosed adnexal mass (the treatment procedure will not be effective to terminate an ectopic pregnancy)

Inherited porphyrias (risk of worsening or of precipitation of attacks)

Use of MIFEPREX and misoprostol for termination of intrauterine pregnancy is contraindicated in patients with an intrauterine device (“IUD”) in place (the IUD might interfere with pregnancy termination). If the IUD is removed, MIFEPREX may be used.

Warnings and Precautions

Infection and Sepsis

As with other types of abortion, cases of serious bacterial infection, including very rare cases of fatal septic shock, have been reported following the use of MIFEPREX. Healthcare providers evaluating a patient who is undergoing a medical abortion should be alert to the possibility of this rare event. A sustained (> 4 hours) fever of 100.4°F or higher, severe abdominal pain, or pelvic tenderness in the days after a medical abortion may be an indication of infection.

A high index of suspicion is needed to rule out sepsis if a patient reports abdominal pain, discomfort, or general malaise (including weakness, nausea, vomiting or diarrhea) more than 24 hours after taking misoprostol. Very rarely, deaths have been reported in patients who presented without fever, with or without abdominal pain, but with leukocytosis with a marked left shift, tachycardia, hemoconcentration, and general malaise.

Uterine Bleeding

Uterine bleeding occurs in almost all patients during a medical abortion. Prolonged heavy bleeding (soaking through two thick full-size sanitary pads per hour for two consecutive hours) may be a sign of incomplete abortion or other complications and prompt medical or surgical intervention may be needed to prevent the development of hypovolemic shock. Counsel patients to seek immediate medical attention if they experience prolonged heavy vaginal bleeding following a medical abortion.

Women should expect to experience vaginal bleeding or spotting for an average of 9 to 16 days. Women report experiencing heavy bleeding for a median direction of 2 days. Up to 8% of all subjects may experience some type of bleeding for 30 days or more. In general, the duration of bleeding and spotting increased as the duration of the pregnancy increased.

Mifeprex is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the MIFEPREX REMS Program, because of the risks of serious complications. Notable requirements of the MIFEPREX REMS Program include the following:

Prescribers must be certified with the program by completing the Prescriber Agreement Form.

Patients must sign a Patient Agreement Form.

MIFEPREX must be dispensed to patients only in certain healthcare settings, specifically clinics, medical offices and hospitals by or under the supervision of a certified prescriber

Ectopic Pregnancy

MIFEPREX is contraindicated in patients with a confirmed or suspected ectopic pregnancy because MIFEPREX is not effective for terminating ectopic pregnancies. Healthcare providers should remain alert to the possibility that a patient who is undergoing a medical abortion could have an undiagnosed ectopic pregnancy because some of the expected symptoms experienced with a medical abortion (abdominal pain, uterine bleeding) may be similar to those of a ruptured ectopic pregnancy.

Women who became pregnant with an IUD in place should be assessed for ectopic pregnancy.

Rhesus Immunization

The use of MIFEPREX is assumed to require the same preventive measures as those taken prior to and during surgical abortion to prevent rhesus immunization.

Adverse Reactions

Most common adverse reactions (>15%) are nausea, weakness, fever/chills, vomiting, headache, diarrhea, and dizziness. The frequency of adverse reactions varies between studies and may be dependent on many factors including the patient population and gestational age.

Serious and sometimes fatal infections and bleeding occur very rarely following spontaneous, surgical, and medical abortions, including following MIFEPREX use. No causal relationship between the use of MIFEPREX and misoprostol and these events has been established.

Atypical Presentation of Infection. Patients with serious bacterial infections (e.g., Clostridium sordellii) and sepsis can present without fever, bacteremia or significant findings on pelvic examination. Very rarely, deaths have been reported in patients who presented without fever, with or without abdominal pain, but with leukocytosis with a marked left shift, tachycardia, hemoconcentration, and general malaise. A high index of suspicion is needed to rule out serious infection and sepsis.

Prolonged heavy bleeding may be a sign of incomplete abortion or other complications and prompt medical or surgical intervention may be needed. Advise patients to seek immediate medical attention if they experience prolonged heavy vaginal bleeding.

Because of the risks of serious complications described above, MIFEPREX is only available through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the MIFEPREX REMS Program. Please see additional Important Safety Information and the Full Prescribing Information.

Before prescribing MIFEPREX, inform the patient about these risks. Ensure the patient knows whom to call and what to do, including going to an Emergency Room if none of the provided contacts are reachable, if she experiences sustained fever, severe abdominal pain, prolonged heavy bleeding, or syncope, or if she experiences abdominal pain or discomfort or general malaise (including weakness, nausea, vomiting or diarrhea) for more than 24 hours after taking misoprostol.

Advise the patient to take the MEDICATION GUIDE with her if she visits an emergency room or another healthcare provider who did not prescribe MIFEPREX, so that provider knows that she is undergoing a medical abortion.

Inherited porphyrias (risk of worsening or of precipitation of attacks)

Use of MIFEPREX and misoprostol for termination of intrauterine pregnancy is contraindicated in patients with an intrauterine device (“IUD”) in place (the IUD might interfere with pregnancy termination). If the IUD is removed, MIFEPREX may be used.

Warnings and Precautions

Infection and Sepsis

As with other types of abortion, cases of serious bacterial infection, including very rare cases of fatal septic shock, have been reported following the use of MIFEPREX. Healthcare providers evaluating a patient who is undergoing a medical abortion should be alert to the possibility of this rare event. A sustained (> 4 hours) fever of 100.4°F or higher, severe abdominal pain, or pelvic tenderness in the days after a medical abortion may be an indication of infection.

A high index of suspicion is needed to rule out sepsis if a patient reports abdominal pain, discomfort, or general malaise (including weakness, nausea, vomiting or diarrhea) more than 24 hours after taking misoprostol. Very rarely, deaths have been reported in patients who presented without fever, with or without abdominal pain, but with leukocytosis with a marked left shift, tachycardia, hemoconcentration, and general malaise.

Uterine Bleeding

Uterine bleeding occurs in almost all patients during a medical abortion. Prolonged heavy bleeding (soaking through two thick full-size sanitary pads per hour for two consecutive hours) may be a sign of incomplete abortion or other complications and prompt medical or surgical intervention may be needed to prevent the development of hypovolemic shock. Counsel patients to seek immediate medical attention if they experience prolonged heavy vaginal bleeding following a medical abortion.

Women should expect to experience vaginal bleeding or spotting for an average of 9 to 16 days. Women report experiencing heavy bleeding for a median direction of 2 days. Up to 8% of all subjects may experience some type of bleeding for 30 days or more. In general, the duration of bleeding and spotting increased as the duration of the pregnancy increased.

Mifeprex is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the MIFEPREX REMS Program, because of the risks of serious complications. Notable requirements of the MIFEPREX REMS Program include the following:

Prescribers must be certified with the program by completing the Prescriber Agreement Form.

Patients must sign a Patient Agreement Form.

MIFEPREX must be dispensed to patients only in certain healthcare settings, specifically clinics, medical offices and hospitals by or under the supervision of a certified prescriber

Ectopic Pregnancy

MIFEPREX is contraindicated in patients with a confirmed or suspected ectopic pregnancy because MIFEPREX is not effective for terminating ectopic pregnancies. Healthcare providers should remain alert to the possibility that a patient who is undergoing a medical abortion could have an undiagnosed ectopic pregnancy because some of the expected symptoms experienced with a medical abortion (abdominal pain, uterine bleeding) may be similar to those of a ruptured ectopic pregnancy.

Women who became pregnant with an IUD in place should be assessed for ectopic pregnancy.

Rhesus Immunization

The use of MIFEPREX is assumed to require the same preventive measures as those taken prior to and during surgical abortion to prevent rhesus immunization.

Adverse Reactions

Most common adverse reactions (>15%) are nausea, weakness, fever/chills, vomiting, headache, diarrhea, and dizziness. The frequency of adverse reactions varies between studies and may be dependent on many factors including the patient population and gestational age.